The quantitative determination of analytes in body fluids is of great importance in the diagnoses and maintenance of certain physiological abnormalities. For example, lactate, cholesterol and bilirubin should be monitored in certain individuals. In particular, determining glucose in body fluids is important to diabetic individuals who must frequently check their blood glucose levels to regulate the glucose intake in their diets.
One method of obtaining a body fluid sample, such as a whole blood sample, is to use a lancing device. For example, a disposable lancing device may be utilized as a one-time means of collecting a whole blood sample. After the single use lancing device has been utilized, it is then discarded and a second disposable lancing device can be used to obtain a sample at a later time. The whole blood sample may then be used to determine the glucose concentration of an individual.
Existing lancing devices use a lancet to pierce the tissue of the skin, allowing a blood sample to form on the skin's surface. Typically, lancing devices hold the lancet within them when the lancet is not in use, so as to shield the user from injury as well as to assist in preventing or inhibiting contamination. Single use lancing devices are typically purchased in a cocked position, wherein the depression of a firing button or other mechanism causes the lancing device to fire—extending the lancet outside of the lancing device. One problem associated with typical disposable lancing devices is that of premature or accidental firing. When a disposable lancing device is prematurely or accidentally fired, it effectively becomes inoperative (useless) for obtaining a fluid sample. Further, in certain circumstances, the accidental firing can pose a threat of unintended punctures to a user or other individual.
It is intended that a disposable lancing device be discarded after performing a single puncture. Unlike multi-use lancing devices, disposable lancing devices include an attached lancet that can not be removed from the lancing device or replaced. As such, once the lancet has been used to puncture the skin of a test subject, the lancet becomes contaminated by the fluid sample and a new, sanitary lancet cannot be inserted. As such, the reuse of disposable lancing devices can pose various medical and health risks to a user.
Additionally, because single use lancing devices are intended to be utilized once and then discarded, it is desirable to produce the lancing devices at a minimal cost. Currently, disposable lancing devices are not particularly easy to assemble. Standard lancing devices are typically made using a “top down” method that requires numerous components to be assembled—each component requiring a distinct mold for its production. The numerous components are then inserted into a housing that completely surrounds a portion of the components. As such, the size of the lancet, and any protective cap associated therewith must be sufficiently small to extend out of an aperture formed in the housing. Due to this “top down” assembly method, lancets are not easily assembled because the handled components tend to be small and are inserted into the surrounding housing.
It would be desirable to have a disposable lancing device and a method for using the same that addresses these issues.